tetano
Editor, Senior Moderator
PLoS One
. 2021 Dec 31;16(12):e0262159.
doi: 10.1371/journal.pone.0262159. eCollection 2021.
The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
Asami Naito[SUP] 1 [/SUP], Yoshihiko Kiyasu[SUP] 2 3 [/SUP], Yusaku Akashi[SUP] 2 4 [/SUP], Akio Sugiyama[SUP] 5 [/SUP], Masashi Michibuchi[SUP] 5 [/SUP], Yuto Takeuchi[SUP] 2 3 [/SUP], Shigeyuki Notake[SUP] 6 [/SUP], Koji Nakamura[SUP] 6 [/SUP], Hiroichi Ishikawa[SUP] 7 [/SUP], Hiromichi Suzuki[SUP] 2 3 8 [/SUP]
Affiliations
Abstract
Introduction: GENECUBE® is a rapid molecular identification system, and previous studies demonstrated that GENECUBE® HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples. However, other respiratory samples have not been evaluated.
Methods: This prospective comparison between GENECUBE® HQ SARS-CoV-2 and reference real-time reverse transcriptase polymerase chain reaction (RT-PCR) was performed for the detection of SARS-CoV-2 using anterior nasal samples and saliva samples. Additionally, we evaluated a new rapid examination protocol using GENECUBE® HQ SARS-CoV-2 for the detection of SARS-CoV-2 with saliva samples. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 35 minutes.
Results: For 359 anterior nasal samples, the total-, positive-, and negative concordance of the two assays was 99.7% (358/359), 98.1% (51/52), and 100% (307/307), respectively. For saliva samples, the total-, positive-, and negative concordance of the two assays was 99.6% (239/240), 100% (56/56), and 99.5% (183/184), respectively. With the new protocol, total-, positive-, and negative concordance of the two assays was 98.8% (237/240), 100% (56/56), and 98.4% (181/184), respectively. In all discordance cases, SARS-CoV-2 was detected by additional molecular examinations.
Conclusion: GENECUBE® HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.
. 2021 Dec 31;16(12):e0262159.
doi: 10.1371/journal.pone.0262159. eCollection 2021.
The evaluation of the utility of the GENECUBE HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
Asami Naito[SUP] 1 [/SUP], Yoshihiko Kiyasu[SUP] 2 3 [/SUP], Yusaku Akashi[SUP] 2 4 [/SUP], Akio Sugiyama[SUP] 5 [/SUP], Masashi Michibuchi[SUP] 5 [/SUP], Yuto Takeuchi[SUP] 2 3 [/SUP], Shigeyuki Notake[SUP] 6 [/SUP], Koji Nakamura[SUP] 6 [/SUP], Hiroichi Ishikawa[SUP] 7 [/SUP], Hiromichi Suzuki[SUP] 2 3 8 [/SUP]
Affiliations
- PMID: 34972195
- DOI: 10.1371/journal.pone.0262159
Abstract
Introduction: GENECUBE® is a rapid molecular identification system, and previous studies demonstrated that GENECUBE® HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples. However, other respiratory samples have not been evaluated.
Methods: This prospective comparison between GENECUBE® HQ SARS-CoV-2 and reference real-time reverse transcriptase polymerase chain reaction (RT-PCR) was performed for the detection of SARS-CoV-2 using anterior nasal samples and saliva samples. Additionally, we evaluated a new rapid examination protocol using GENECUBE® HQ SARS-CoV-2 for the detection of SARS-CoV-2 with saliva samples. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 35 minutes.
Results: For 359 anterior nasal samples, the total-, positive-, and negative concordance of the two assays was 99.7% (358/359), 98.1% (51/52), and 100% (307/307), respectively. For saliva samples, the total-, positive-, and negative concordance of the two assays was 99.6% (239/240), 100% (56/56), and 99.5% (183/184), respectively. With the new protocol, total-, positive-, and negative concordance of the two assays was 98.8% (237/240), 100% (56/56), and 98.4% (181/184), respectively. In all discordance cases, SARS-CoV-2 was detected by additional molecular examinations.
Conclusion: GENECUBE® HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.
